FDA warns of injuries, deaths from herbal supplement

WASHINGTON — Federal health authorities are warning about reports of injury, addiction and death with a herbal supplement that has been promoted as an alternative to opioid painkillers and other prescription drugs.

The supplement, kratom, is made from a plant native to Southeast Asia. It has gained popularity in the U.S. as a treatment for pain, anxiety and drug dependence. Users have opposed efforts to regulate the plant, saying it could be a safer alternative to opioid pain pills.

But the Food and Drug Administration said Tuesday that kratom carries similar risks, including addiction and death, and the agency is working to block shipments.

The FDA said it is aware of 36 deaths involving products made with kratom and hundreds of calls to poison control centers.

“There is no reliable evidence to support the use of kratom as a treatment for opioid use disorder,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “Patients addicted to opioids are using kratom without dependable instructions for use and more importantly, without consultation with a licensed health care provider about the product’s dangers, potential side effects or interactions with other drugs.”

Last year, the Drug Enforcement Administration had planned to temporarily ban kratom and add the two psychoactive components of the plant to the list of the most dangerous drugs, but it reversed the decision before it was implemented after public opposition. The agency said it wait for a recommendation from the FDA before deciding kratom’s fate.

In a statement, Gottlieb said in response to the DEA’s request, the FDA has conducted a comprehensive scientific and medical evaluation of two compounds found in kratom.

He said that while the FDA remains open to the potential medicinal uses of kratom, “those uses must be backed by sound science and weighed appropriately against the potential for abuse.”

“We’ve learned a tragic lesson from the opioid crisis: that we must pay early attention to the potential for new products to cause addiction and we must take strong, decisive measures to intervene,” Gottlieb said. “From the outset, the FDA must use its authority to protect the public from addictive substances like kratom, both as part of our commitment to stemming the opioid epidemic and preventing another from taking hold.”